Molecular and Genetic Characterization of Inborn Errors of Immunity (R21 Clinical Trial Not Allowed) | PAR 19 079

Opportunity Information: Apply for PAR 19 079

Molecular and Genetic Characterization of Inborn Errors of Immunity (R21 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number PAR-19-079; CFDA 93.855) focused on early-stage, exploratory research that clarifies how specific genetic changes cause inborn errors of immunity, also known as primary immunodeficiency diseases. The central goal is to push beyond gene discovery by supporting experimental validation and functional characterization of variants found in either coding regions (that alter proteins) or non-coding regions (that can disrupt gene regulation). Projects supported under this announcement are expected to explain, in a mechanistic and biologically convincing way, how a candidate variant leads to immune dysfunction at the molecular, cellular, and immunological levels.

This FOA emphasizes research that turns genetic findings into evidence-based disease mechanisms. In practical terms, that means applicants are encouraged to move from a suspected disease-associated variant to demonstration of its functional impact using appropriate experimental systems. That could include showing how a variant alters gene expression, protein function, signaling pathways, cell development, or immune responses, and then linking those disruptions to clinically relevant immune phenotypes. The intended outcome is a clearer genetic and mechanistic foundation for these disorders, which directly supports improved diagnosis and prognosis and helps create a pathway toward precision therapeutics (for example, identifying actionable targets, rationally selecting existing drugs, or informing development of new interventions).

The mechanism is an NIH R21, which is typically used for innovative, higher-risk studies that generate strong preliminary evidence, new methods, or proof-of-concept data that can later be expanded under larger awards. The listed award ceiling is $200,000. As indicated by the title, clinical trials are not allowed under this specific opportunity, so the work should be preclinical or mechanistic rather than interventional studies in human participants. Human data can still be relevant in many R21 contexts (for example, using de-identified samples, observational data, or ex vivo analyses), but the FOA framing makes clear that applicants should not propose a clinical trial as defined by NIH.

Eligibility is broad and includes many organization types, reflecting an interest in drawing strong proposals from universities, medical and research institutions, nonprofits, government entities, and industry. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This inclusive eligibility structure supports participation by a wide range of research and community-serving institutions, including those serving underrepresented populations and those located outside the continental United States.

The opportunity was created on November 26, 2018, and the original closing date listed in the source data is January 7, 2022. Overall, this FOA is designed to accelerate rigorous mechanistic studies that connect genetic variants to immune system defects, strengthening the evidence base needed for more accurate molecular diagnosis and for future development of targeted, precision approaches to treatment for patients with inborn errors of immunity.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Molecular and Genetic Characterization of Inborn Errors of Immunity (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2018-11-26.
• Applicants must submit their applications by 2022-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 19 079

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